The following data is part of a premarket notification filed by Cardio Metrics, Inc. with the FDA for Stableline.
Device ID | K860298 |
510k Number | K860298 |
Device Name: | STABLELINE |
Classification | Accessory Equipment, Cardiopulmonary Bypass |
Applicant | CARDIO METRICS, INC. 10415 LANDSBURY DR. Houston, TX 77099 |
Contact | Mary K Noonen |
Correspondent | Mary K Noonen CARDIO METRICS, INC. 10415 LANDSBURY DR. Houston, TX 77099 |
Product Code | KRI |
CFR Regulation Number | 870.4200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-28 |
Decision Date | 1986-04-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STABLELINE 78745256 3140736 Dead/Cancelled |
MILLER MANUFACTURING COMPANY 2005-11-02 |